Health Ministry bans 328 fixed dose combination drugs

Health Ministry bans 328 fixed dose combination drugs

News:

1. The Ministry of Health and Family Welfare (MoHFW) has prohibited the manufacture, sale or distribution of 328 fixed dose combinations (FDCs) for human use with immediate effect.

FDCs : A drug which contains two or more active ingredients in a fixed dosage ratio.

The FDC formulation may have up to 5 or even more ingredients with or without rationality of their presence and in the quantity.

Important Facts:

2. The prohibition is done under the Section 26 A of the Drugs and Cosmetics Act, 1940 .
3. The ban on FDCs will  include painkillers, anti-diabetic, respiratory and gastrointestinal medicines, covering 6,000 brands.
4. The ban notifications do not include 15 FDCs that were manufactured since before 1988.
5. The MoHFW earlier in 2016, had banned 349 FDCs but Supreme Court(SC) stayed it after drug manufacturers petitioned .
6. SC also directed to form an expert panel by the DTAB to review the matter.
7. Findings of the Expert Panel formed under Chairmanship of NilimaKshirsagar:

• These FDCs were “irrational” and have  lack of therapeutic justification.

• Many FDCs were formulated without due diligence, with dosing mismatches that could result in toxicity.
• FDCs may raise safety issues for human beings.

8. Central Government considered the recommendations of the Expert Committee and concluded that it was expedient in public interest to prohibit these 328 FDCs.
9. General issues with FDCs:

• Pharmacodynamic mismatch between two FDC components i.e., having opposite effects leading to reduced efficacy or enhanced toxicity,
• Pharmacokinetic mismatch between components with peak efficacy at different times.
• Chemical non-compatibility leading to decreased shelf life.

10. Impact of the FDCs ban:

• Ban will shave off over Rs1,500 crore from India’s Rs1.18-lakh crore pharmaceutical industry.
• It would also  impact medicine brands across several therapy areas.
• However the impact of this ban is expected to be limited as most of these brands are “very small” and  ban may have a “marginal” impact.
•  Moreover the drug makers with FDCs banned between 2016 and 2017 have either changed the compositions of their combinations or discontinued production of some brands that fell into the ‘banned’ category.
• Companies can  launch variants to FDCs that would be compliant with regulations.